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CompletedNCT00771264SUmiTUpdated Apr 18, 2012Results posted

Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms

A Phase 4 interventional study of Urgent PC Neuromodulation System in Overactive Bladder, sponsored by Uroplasty, Inc. Completed at 15 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-18.

Sponsored by Uroplasty, Inc · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.

02

Conditions studied

  • Overactive Bladder

Keywords

  • Overactive Bladder
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 220 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Uroplasty, Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women and men >18 years of age
  • A score of > 4 on the OAB-q short form for urgency (question 1)
  • Average urinary frequency > 10 times in one 24 hour day based on a 3-day voiding diary
  • Self-reported bladder symptoms present > 3 months
  • Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
  • Off all antimuscarinics for at least 2 weeks prior to enrollment
  • Capable of giving informed consent
  • Ambulatory and able to use a toilet independently, without difficulty
  • Capable and willing to follow all study-related procedures

Exclusion criteria

Exclusion Criteria:

  • Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
  • Neurogenic bladder
  • Botox use in bladder or pelvic floor muscles in the past year
  • Pacemakers or implantable defibrillators
  • Primary complaint of stress urinary incontinence
  • Current urinary tract infection (UTI)
  • Current vaginal infection
  • Current use of InterStim
  • Current use of Bion
  • Current use of TENS in the pelvic region, back or legs
  • Previously been treated with PTNS
  • Use of investigational drug/device therapy within the past 4 weeks
  • Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
  • Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy)
  • Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Active comparator
    Urgent PC

    Device: Urgent PC Neuromodulation System

  • No intervention
    Sham / Placebo

Interventions

  • DeviceUrgent PC Neuromodulation System

    The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

06

What researchers measure

Primary outcomes

  1. The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.

    A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.

    Time frame: 13 weeks

07

Results

Posted Sep 21, 2010

Participant flow

Subjects were recruited by investigator sites with limited advertising

Participant flow — Overall Study
MilestoneUrgent PCSham / Placebo
Started110110
Completed103105
Not completed75

Outcome measures

PrimaryThe Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.

A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.

Time frame:
13 weeks
Reported as:
Number · participants
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.
participantsUrgent PCSham / Placebo
The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis.6023
Statistical analysis
  • Urgent PC vs Sham / Placebo · t-test, 2 sided · p = 0.05 (P-values \<0.05 were considered statistically significant.)Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Urgent PC—0/110 (0%)6/110 (5.5%)
Sham / Placebo—0/110 (0%)0/110 (0%)
Most frequent other events
Most frequent other events
EventUrgent PCSham / Placebo
bleeding at needle siteSurgical and medical procedures3/1100/110
discomfort at needle siteSurgical and medical procedures2/1100/110
ankle bruisingSurgical and medical procedures1/1100/110
tingling in legSurgical and medical procedures1/1100/110

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Urgent PCSham / PlaceboTotal
<=18 years000
Between 18 and 65 years5464118
>=65 years5646102
Age Continuous
Age Continuous(years)Urgent PCSham / PlaceboTotal
Mean62.5 ± 14.660.2 ± 15.261.3 ± 14.9
Sex: Female, Male
Sex: Female, Male(Participants)Urgent PCSham / PlaceboTotal
Female8688174
Male242246
Region of Enrollment
Region of Enrollment(participants)Urgent PCSham / PlaceboTotal
United States110110220
08

Study locations

15 sites
  • Gregory L. Davis, M.D., FACOG, Inc.
    Chico, California 95928, United States
  • Greenwich Urological Associates, P.C.
    Greenwich, Connecticut 06830, United States
  • Specialists in Urology
    Naples, Florida 34102, United States
  • Mercy Health Partners at the Lakes
    Muskegon, Michigan 49444, United States
  • Beaumont Hospital
    Royal Oak, Michigan 48703, United States
  • Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan
    Grand Rapids, Minnesota 49503, United States
  • Uroplasty, Inc
    Minnetonka, Minnesota 55343, United States
  • Beaumont Hospital
    Royal Oak, Minnesota 48073, United States
  • Urology Health Center, PC
    Fremont, Nebraska 68025, United States
  • Capital Region Urological Surgeons, PLLC
    Albany, New York 12208, United States
  • Central Missouri Women's Healthcare, LLC
    White Plains, New York 10604, United States
  • Alliance Urology Specialists
    Greensboro, North Carolina 27403, United States
  • University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
  • Virginia Urology
    Richmond, Virginia 23235, United States
  • Athena Urology
    Issaquah, Washington 98027, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00771264
Lead sponsor
Uroplasty, Inc
Responsible party
Sponsor
First posted
Oct 13, 2008
Start date
Sep 2008
Primary completion
Jun 2009
Completion
Jun 2009
Results posted
Sep 21, 2010
Last update
Apr 18, 2012
View the source record on ClinicalTrials.gov ↗

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